Select Ongoing Trials Currently Enrolling Patients with Systemic Lupus Erythematosus

The following clinical trials represent a selection of key studies that are currently recruiting patients with systemic lupus erythematosus for inclusion in investigations of new therapies and new regimens of existing treatments for patients with systemic lupus erythematosus. Each clinical trial description includes the NLM Identifier to be used as a reference with ClinicalTrials.gov. The information below can help rheumatology practice managers and providers direct their eligible patients to one of these clinical trials.

1 Dapirolizumab Pegol in Moderate-to-Severe Active Systemic Lupus Erythematosus

The purpose of this multicenter, randomized, double-blind, placebo- controlled, phase 3 clinical trial is to evaluate the ability of dapirolizumab pegol, an anti-CD40L pegylated Fab fragment, as an add-on treatment to the standard of care in patients with moderate-to-severe active systemic lupus erythematosus (SLE) to achieve clinically relevant long-term improvement of disease activity. Patients aged ≥16 years with moderate-to-severe disease activity due to persisting or acute worsening of SLE despite stable standard-of-care treatment, who have Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) ≥6 at screening visit and ≥4 without labs at baseline, and who have British Isles Lupus Assessment Group Disease Activity Index 2004 (BILAG 2004) Grade B in ≥2 organ systems or Grade A in ≥1 organ systems may be eligible if other criteria are met. Eligible patients will be randomized to receive either dapirolizumab pegol or placebo throughout the treatment period at prespecified time points.

The primary outcome measure is achievement of BILAG 2004–based Composite Lupus Assessment (BICLA) of BILAG 2004 improvement without worsening, no worsening in the SLEDIA-2K total score, and no worsening in the Physician’s Global Assessment of Disease. Secondary outcome measures include BICLA response at weeks 12 and 24, the prevention of moderate or severe BILAG flares through week 48, achievement of low lupus disease activity state (LLDAS), and percentage of participants with treatment-emergent adverse events (TEAEs). This study expects to enroll 450 participants throughout the United States and worldwide. For more information, contact UCB Biopharma Cares at UCBCares@ucb.com. The NLM identifier is NCT04294667.

2 Branebrutinib in Active SLE or Primary Sjögren’s Syndrome, or Branebrutinib Treatment Followed by Abatacept in Active Rheumatoid Arthritis

The purpose of this randomized, placebo-controlled, double-blind, multicenter phase 3 clinical trial is to assess the safety and efficacy of branebrutinib (BMS-986195) in patients with active SLE or primary Sjögren’s syndrome, or branebrutinib treatment followed by abatacept in patients with active rheumatoid arthritis. Patients aged ≥18 years with either active SLE diagnosed >24 weeks before screening visit, moderate-to-severe primary Sjögren’s syndrome, or moderate- to-severe adult-onset rheumatoid arthritis with American College of Rheumatology (ACR) global functional status class I to III may be eligible if other criteria are met. Eligible patients will be randomized to receive either branebrutinib or placebo on specified days for SLE, branebrutinib or placebo on specified days for primary Sjögren’s syndrome, or branebrutinib on specified days and abatacept 125 mg once weekly or abatacept 125 mg once weekly plus placebo on specified days for rheumatoid arthritis.

The primary outcome measures include moderate Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) activity score with a ≥50% reduction from baseline; proportion of patients with changes in composite score that includes European League Against Rheumatism (EULAR) Sjögren’s Syndrome Patient Report Index (ESSPRI) and EULAR Sjögren’s Syndrome Disease Activity Index (ESSDAI); and proportion of patients achieving ACR50 response. Secondary outcome measures include SLEDAI-2K score change from baseline, BICLA response, disease activity score 28 (DAS28) for C-reactive protein and erythrocyte sedimentation rate, and the incidence of serious adverse events. This study plans to enroll 185 participants throughout the United States and worldwide. For more information, contact the recruiting sites directly, or Clinical.Trials@bms.com. The first line of the e-mail MUST contain the NCT # and Site #. The NLM identifier is NCT04186871.

3 Efficacy and Safety of Dose-Ranging PF-06700841 in Active SLE

The purpose of this double-blind, randomized, placebo-controlled, multicenter, phase 2B clinical trial is to evaluate the safety and efficacy of PF-06700841, an oral TYK2/JAK1 inhibitor, in patients with moderate-to-severe active, generalized SLE who have had an inadequate response to standard of care. Patients aged 18 to 75 years with moderate-to-severe active SLE who are receiving a stable dose of methotrexate, azathioprine (Imuran), leflunomide (Arava), mizoribine (Bredinin), mycophenolate (Myfortic)/mycophenolic acid, antimalarias, or corticosteroids may be eligible if other criteria are met. Eligible patients will be randomized to receive PF-06700841 in doses of 15 mg, 30 mg, or 45 mg, or placebo.

The primary outcome measure is the proportion of patients achieving the Systemic Lupus Erythematosus Responder Index (SRI) change of 4 at week 52. Secondary outcome measures include time to first severe flare in patients receiving PF-06700841 relative to patients receiving placebo, proportion of patients achieving LLDAS at week 52, proportion of patients achieving a reduction in corticosteroid, number of TEAEs, discontinuation due to adverse events, and number of clinically significant abnormalities in vital signs, electrocardiograms, and laboratory values. This study plans to enroll 448 participants throughout the United States and worldwide. For more information, contact Pfizer CT.gov Call Center at 1-800-718-1021 or ClinicalTri als.gov_Inquiries@pfizer.com. The NLM identifier is NCT03845517.

4 Addition of Obinutuzumab to Standard-of-Care Therapy in Patients with ISN/RPS 2003 Class III or IV Lupus Nephritis

The purpose of this randomized, double-blind, placebo-controlled, multicenter, phase 3 clinical trial is to evaluate the efficacy, safety, and pharmacokinetics of adding obinutuzumab (Gazyva) to the standard-of-care therapy, mycophenolate mofetil plus corticosteroids, in patients with International Society of Nephrology/Renal Pathology Society (INS/RPS) class III or IV lupus nephritis. Patients aged 18-75 years with a diagnosis of ISN/RPS 2003 class III or IV lupus nephritis as evidenced by renal biopsy performed within 6 months and who have a urine protein to creatinine ratio ≥1 in a 24-hour collection may be eligible if other criteria are met. Patients will be randomized into 2 treatment arms. Treatment arm 1 will receive obinutuzumab 1000 mg intravenous (IV) at baseline and weeks 2, 24, 26, 50, and 52, and subsequently from week 80 and every 6 months thereafter, plus standard-of-care therapy. Treatment arm 2 will receive standard-of-care therapy plus placebo infusion at week 50. Patients who achieve an adequate response at week 76 will continue with the blinded infusions, while patients who did not have an adequate response may be eligible for open-label obinutuzumab.

The primary outcome measure is the percentage of patients with complete renal response. Secondary outcome measures include the percentage of patients with overall renal response, change in SLEDAI-2K activity, change in estimated glomerular filtration rate, percentage of patients with adverse events according to the National Cancer Institute’s Common Terminology Criteria for Adverse Events version 5.0, maximum serum concentration of obinutuzumab, and change from baseline in total peripheral B-cell count. This study plans to enroll 250 participants throughout the United States and worldwide. For more information, contact Hoffmann-La Roche at 1-888-662-6728 or global.rochege nentechtrials@roche.com, and include reference study ID number CA41705. The NLM identifier is NCT04221477.

5 Cenerimod versus Placebo in Adults with Active Moderate-to Severe, Autoantibody-Positive SLE

The purpose of this multicenter, multinational, randomized, double- blind, placebo-controlled, phase 2B clinical trial is to assess the efficacy and safety of 4 doses of cenerimod, a potent, orally active, selective S1P1 receptor modulator, versus placebo in adult patients with moderate-to->severely active, autoantibody-positive SLE. Patients aged 18 to 75 years who have been diagnosed with SLE at least 6 months prior to screening and have ≥4 of 11 SLE criteria defined by the ACR, who have a SLEDAI-2K score ≥6 of at least 2 points for musculoskeletal or mucocutaneous manifestations, who are currently treated with stable doses of background medications for SLE, and who have a history or presence of positive antinuclear antibody (ANA) titer ≥1:80 and/or positive antidouble-stranded deoxyribonucleic acid (anti-dsDNA) antibodies titer ≥30 IU/mL. Patients will be randomized to receive either cenerimod 0.5 mg, 1 mg, 2 mg, or 4 mg, or placebo.

The primary outcome measure is the change from baseline to month 6 in modified SLEDAI score, which excludes leukopenia. The secondary outcome measures are response on SRI-4 at month 6 compared with baseline, and percent of patients with no new organ system affected compared with baseline. This study plans to enroll 500 participants throughout the United States and worldwide. For more information, contact the Idorsia Pharmaceuticals Clinical Trials Disclosure Desk at 1-856-661-3721 or clinical-trials-disclosure@idorsia.com. The NLM identifier is NCT03742037.

6 AMG 570 as Therapeutic Agent in Current Treatment Landscape for Patients with SLE with Ongoing Disease Activity Despite Standard-of-Care Treatment

The purpose of this multicenter, double-blind, randomized, placebo- controlled, dose-ranging, adaptive phase 2 clinical trial is to study the efficacy of AMG 570, a bispecific molecule targeting T-cell and B-cell activity, as a useful therapeutic agent in the current treatment landscape for patients with SLE whose disease has an inadequate response to current standard-of-care therapies, including oral corticosteroids, immunosuppressants, and immunomodulators. Patients aged 18 to 75 years with diagnosed SLE according to 2019 EULAR/ACR classification criteria with ANA titer ≥1:80 by immunofluorescence Hep-2 cells present at screening and anti-dsDNA results based on the Farr assay, who have arthritis of the hands or wrists, alopecia, scleritis and episcleritis, and who have a urine protein-to-creatinine ratio <3000 mg/g in a clean-catch specimen may be eligible if other criteria are met. Patients will be randomized to receive either placebo in a 5-mL glass vial or 1 of 3 doses of AMG 570 in a 5-mL glass vial.

The primary outcome measure is the percent of patients achieving SRI-4 response at week 24, defined as a ≥4 point decrease in hybrid SLEDAI score, no new BILAG 2004 A domain score and no greater than 1 new BILAG 2004 B scores compared with baseline, and <0.3 point deterioration from baseline in Physician Global Assessment. Secondary outcome measures include CLASI activity score ≥50% improvement from baseline of CLASI activity score ≥8, incidence of TEAEs and serious adverse events, serum AMG 570 trough concentrations and terminal elimination half-life, and percentage of patients achieving LLDAS at week 52. This study plans to enroll 300 participants throughout the United States and worldwide. For more information, contact the Amgen Call Center at 1-866-572-6436 or medinfo@amgen.com. The NLM identifier is NCT04058028.

7 Hydroxychloroquine Treatment in Incomplete Systemic Lupus Erythematosus with Significant Levels of ANAs

The purpose of this randomized, parallel, quadruple-masking, phase 2 clinical trial is to study the efficacy of treating patients with incomplete systemic lupus erythematosus who have significant levels of ANAs with hydroxychloroquine (Plaquenil). Patients aged 15 to 49 years with an ANA titer of ≥1:80 as determined by immunofluorescence assay and who have ≥1 to 3 additional clinical or laboratory criterion from the 2012 Systemic Lupus International Collaborating Clinics (SLICC) classification criteria may be eligible if other criteria are met. Eligible patients will be randomized to receive a hydroxychloroquine 200 or 400 mg dose once daily based on the patient’s weight for 96 weeks, or placebo oral capsule once or twice daily as a single dose based on the patient’s weight for 96 weeks.

The primary outcome measure is SLICC score measured every 12 weeks for 96 weeks. Secondary outcome measures include time to disease progression, disease activity index measured by SLEDAI and CLASI, patient-reported outcomes, ophthalmologic toxicity, and immunologic mediators. This study plans to enroll 240 participants throughout the United States. For more information, contact Nancy J. Olsen, MD, at 1-717-531-4921 or nolsen@pennstatehealth.psu.edu or David R. Karp, MD, PhD, at 1-214-648-9110 or David.karp@utsouthwestern.edu. The NLM identifier is NCT03030118.

8 Potential First-in-Class Therapeutic, LY3471851, an IL-2 Receptor Inhibitor, in Adults with SLE

The purpose of this randomized, double-blind, placebo-controlled, phase 2 clinical trial is to assess the safety and efficacy of LY3471851 (NKTR-358), an interleukin-2 (IL-2) receptor inhibitor that targets the proliferation of regulatory T-cells to balance the immune system, as a potential first-in-class therapeutic to address the underlying immune system imbalance in adults with SLE. Patients aged 18 to 65 years who have a clinical diagnosis of SLE at least 24 weeks prior to screening, have documentation of ≥4 of 11 ACR SLE classification criteria, have an SLEDAI-2K score ≥6 at screening and ≥4 at randomization, and who have active arthritis and/or active rash may be eligible if other criteria are met. Eligible patients will be randomized to receive either a high dose, a mid-dose, or a low dose of LY3471851 via subcutaneous, or placebo via subcutaneous.

The primary outcome measure is the percentage of patients who achieve a ≥4-point reduction in SLEDAI-2K score. Secondary outcome measures include percentage of patients who achieve BICLA response and SRI-4 response, percentage of patients who achieve LLDAS, and the trough concentrations of LY3471851. This study plans to enroll 280 participants throughout the United States and worldwide. For more information, contact Eli Lilly and Company/Nektar Therapeutics at 1-877-285-4559 or 1-317-615-4559, or e-mail clinicaltrials.gov@lilly.com. The NLM identifier is NCT04433585.

9 Elsubrutinib plus Upadacitinib Combination versus Elsubrutinib Monotherapy or Upadacitinib Monotherapy in Moderate-to- Severely Active SLE

The purpose of this randomized, quadruple-masking, phase 2 clinical trial is to assess the safety and efficacy of elsubrutinib (ABBV-105) and upadacitinib (Rinvoq) either alone or in combination for the treatment of patients with moderately-to-severely active SLE and to define doses for further development. Patients aged 18 to 65 years with a clinical diagnosis of SLE ≥24 weeks prior to screening; who have an SLEDAI-2K score ≥6, Physician’s Global Assessment ≥1, and who must be receiving stable background treatment for 30 days may be eligible if other criteria are met. Eligible patients will be randomized to receive either elsubrutinib plus upadacitinib combination, elsubrutinib plus placebo, upadacitinib plus placebo, or double placebo.

The primary outcome measure is SRI-4 and steroid use (≤10 mg prednisone equivalent daily). Secondary outcome measures include SLE Responder Index scores, BICLA, percentage of patients achieving ≥4 point decrease in SLEDAI-2K from baseline, change in steroid burden from baseline, time to first flare, and percentage of participants who achieve 50% reduction in the number of tender or swollen lupus joints. This study plans to enroll 310 participants throughout the United States and worldwide. For more information, contact AbbVie Call Center at 1-847-283-8955 or abb vieclinicaltrials@abbvie.com. The NLM identifier is NCT03978520.

10 Subcutaneous Secukinumab in Combination with Standard-of-Care Therapy in Active Lupus Nephritis

The purpose of this randomized, double-blind, parallel-group, placebo-controlled, phase 3 clinical trial is to evaluate the efficacy and safety of subcutaneous secukinumab (Cosentyx) compared with placebo in combination with standard-of-care therapy in patients with active lupus nephritis. Patients aged 18 to 75 years with confirmed diagnosis of SLE as defined by the ACR or lupus nephritis in the presence of ANA or anti-dsDNA antibodies, with an estimated glomerular filtration rate >30 mL/min/1.73 m2, and active urinary sediment may be eligible if other criteria are met. Eligible patients will be randomized to receive secukinumab 300 mg subcutaneous or subcutaneous placebo.

The primary outcome measure is the proportion of patients achieving complete renal response as defined by protocol. Secondary outcome measures include change in 24-hour urine protein-to-creatinine ratio, proportion of patients achieving partial renal response, average daily dose of oral corticosteroids compared with placebo, incidence of TEAEs, and proportion of patients with improved or maintained renal response at week 104. The study plans to enroll 460 participants throughout the United States and worldwide. For more information, contact Novartis Pharmaceuticals at 1-888-669-6682 or Novartis.email@novartis.com. The NLM identifier is NCT04181762.

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